Half-Year 2022 Financial and Clinical Trials Update
Giredestrant (SERD (3),RG6171, GDC-9545)
A selective estrogen receptor degrader or downregulator
Indication
2L/3L ER+/HER2-negative
metastatic breast cancer (mBC)
1L ER+ metastatic breast cancer (mBC)
Adjuvant ER+ breast cancer (BC)
Phase/study
# of patients
Design
Phase II
aceLERA Breast Cancer
N=303
ARM A: Giredestrant monotherapy
ARM B: Endocrine monotherapy (fulvestrant or
aromatase inhibitor)
Phase III
persevERA Breast Cancer
N=978
ARM A: Giredestrant plus palbociclib
ARM B: Letrozole plus palbociclib
Phase III
lidERA Breast Cancer
N=4,100
ARM A: Giredestrant monotherapy
ARM B: Tamoxifen or aromatase inhibitor
■ Progression-free survival
Primary endpoint
■ FPI Q4 2020
Recruitment completed Q4 2021
Status
▪ Study did not meet its primary endpoint Q2 2022
CT Identifier
NCT04576455
ER-Estrogen receptor; HER2-Human Epidermal growth factor Receptor
■ Progression-free survival
■ Invasive disease-free survival
☐
⚫ FPI Q4 2020
NCT04546009
"
FPI Q3 2021
NCT04961996
136
Roche
OncologyView entire presentation